NEW HCPCS Codes for COVID-19 Laboratory Tests
Craneware® Insights Regulatory Updates – CWI1226 (20 April 2020)
NEW HCPCS Codes for COVID-19 Laboratory Tests
On April 14, 2020, CMS posted CMS-Ruling 2020-1-R in which information is provided on COVID-19 laboratory testing using high throughput technologies.
Provider Types Affected
Critical Access Hospitals
Comprehensive Outpatient Rehabilitation Facility
Provider-Based Rural Health Clinics
Compliance / Revenue Integrity
Finance Laboratory – General
What You Need to Know
Medicare Part B pays for clinical diagnostic laboratory tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS) in accordance with section 1833(h) and section 1834A of the Social Security Act (the Act). CDLTs are currently being used to detect SARS-CoV-2 (COVID-19).
This CMS Ruling concerns COVID-19 testing using “high throughput machines”. CMS defines high throughput machines as sophisticated equipment, which require more time intensive processes to ensure quality and more technician training to ensure highly skilled personnel. This technology uses a platform that automates processing of more than two hundred specimens a day. CMS provided the following examples of high throughput technology as of April 14, 2020 to include, but are not limited to:
- Roche cobas 6800 System
- Roche cobas 8800 System
- Abbott m2000 System
- Hologic Panther Fusion System
- GeneXpert Infinity System
- NeuMoDx 288 Molecular
According to CMS, training and processes for the above-mentioned systems represent an increase in resources resulting in a payment rate of $100 for the associated CDLTs. CMS has developed the following HCPCS codes to identify tests that use “high throughput machines”, beginning on or after March 18, 2020:
- U0003: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R.
HCPCS code U0003 identifies tests that would otherwise be reported with CPT® code 87635, which represents the above-listed CDLT without the use of high throughput technology.
- U0004: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R.
HCPCS code U0004 identifies tests that would otherwise be reported with CPT® code U0002, which represents the above-listed CDLT without the use of high throughput technology.
CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that use high throughout technologies, which are developed after the issuance of the Ruling.
CMS states that this Ruling will expire upon the expiration of the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Act.
Hospital and provider offices that process COVID-19 laboratory tests using high throughput technology need to add the new HCPCS codes to their chargemaster(s) and charge capture tools. Laboratory staff and personnel responsible for order entry need to be informed of the new HCPCS codes. Internal audits should be performed subsequent to billing to ensure receipt of accurate reimbursement.
18 March 2020
1834A of the Social Security Act:
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